COMPOGLASS F

K971513 · Ivoclar North America, Inc. · EBF · Jun 3, 1997 · Dental

Device Facts

• Record ID: K971513
• Device Name: COMPOGLASS F
• Applicant: Ivoclar North America, Inc.
• Product Code: EBF · Dental
• Decision Date: Jun 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

Restorations in deciduous teeth - Class V restorations (cervical caries, root erosion, wedge-shaped defects) - Class III restorations - Intermediate Class I and II restorations

Device Story

Compoglass F is a dental restorative material used by dentists for filling cavities. It is indicated for deciduous teeth, Class V, Class III, and intermediate Class I and II restorations. The material is applied directly to the prepared tooth cavity by the clinician to restore form and function. It serves as a restorative agent to treat dental caries and defects. The device is intended for prescription use only.

Technological Characteristics

Dental restorative material; composition includes fluoride-releasing components (implied by 'F' in name).

Indications for Use

Indicated for patients requiring dental restorations in deciduous teeth, Class V restorations (cervical caries, root erosion, wedge-shaped defects), Class III restorations, and intermediate Class I and II restorations.

Regulatory Classification

Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Submission Summary (Full Text)

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Federal Aviation Administration

JUN - 3 1997

Food and Drug. Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Peter P. Mancuso 'Ouality Assurance/Requlatory Affairs Manager Ivoclar North America, Incorporated 175 Pineview Drive Amherst, New York 14228

K971513 Re : Compoglass F Trade Name: Requlatory Class: II Product Code: EBF Dated: April 18, 1997 April 28, 1997 Received:

Dear Mr. Mancuso:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Mancuso

This letter will allow you to beqin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or at [phone].

Sincerely yours,

Timothy H. White, chair

Time y A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):

Compoglass F Device Name:

Indications For Use:

- Restorations in deciduous teeth -
- Class V restorations (cervical caries, root erosion, wedge-shaped defects) -
- Class III restorations -
- -Intermediate Class I and II restorations

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Rumm

(Division Sign-Off) Division of Dental, Infection Contr and General Hospital 510(k) Number

Prescription Use (Per 21 CFR 801 1109)

OR

Over-The-Counter Use No

(Optional Format 1-2-96)